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Method for preparing ceftiofur hydrochloride suspension injection

The technology of ceftiofur hydrochloride and suspension injection is applied in the preparation of ceftiofur hydrochloride preparation and the field of preparation of ceftiofur hydrochloride suspension injection, which can solve the problems of low dissolution rate, low bioavailability and the like, and achieve preparation of ceftiofur hydrochloride. Stable performance, simple preparation process and broad application prospects

Active Publication Date: 2012-12-12
SHANGHAI TONGREN PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] Various preparations of existing ceftiofur hydrochloride all have the disadvantages of low dissolution rate and low bioavailability

Method used

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  • Method for preparing ceftiofur hydrochloride suspension injection
  • Method for preparing ceftiofur hydrochloride suspension injection
  • Method for preparing ceftiofur hydrochloride suspension injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0018] Weigh 5.4 g of ceftiofur hydrochloride, place it in a pulverizer, and pulverize until more than 90% of the particle size is ≤20 μm; take 100 mL of injection-grade soybean oil, heat it to 140 ° C in a container, stir and sterilize it for 60 minutes, and cool it to room temperature; Add the pulverized ceftiofur hydrochloride to the soybean oil, and stir to disperse evenly; slowly add sorbitan fatty acid ester under stirring, stir evenly, stir evenly, continue stirring evenly, and completely disperse into a suspension; The obtained suspension is ultra-fine through a homogenizer, and the specific operation is as follows: put the suspension of ceftiofur hydrochloride into four stainless steel containers in a high-performance ball mill, start the ball mill for 5 to 10 minutes, and grind the suspension into fine particles , making more than 90% of the particles ≤ 15 μm, the ceftiofur hydrochloride suspension injection is obtained.

[0019] The obtained ceftiofur hydrochloride ...

Embodiment 2

[0023] Weigh 5.6 g of ceftiofur hydrochloride, place it in a pulverizer, and pulverize until more than 90% of the particle size is ≤20 μm; take 100 mL of injection-grade soybean oil, heat it to 145 ° C in a container, stir and sterilize it for 55 minutes, and cool it to room temperature; Add the pulverized ceftiofur hydrochloride to the soybean oil, and stir to disperse evenly; slowly add sorbitan fatty acid ester under stirring, stir evenly, stir evenly, continue stirring evenly, and completely disperse into a suspension; Put the ceftiofur hydrochloride suspension into four stainless steel containers in a high-performance ball mill, start the ball mill for 5 to 10 minutes, and grind the suspension so that more than 90% of the particles are ≤15 μm to obtain the ceftiofur hydrochloride Furan suspension injection.

[0024] The obtained ceftiofur hydrochloride suspension injection was tested according to the 2006 edition of the imported veterinary drug quality standard and the ap...

Embodiment 3

[0028] Weigh 5.7 g of cefotaxime hydrochloride, put it into a pulverizer and pulverize until more than 90% of the particles have a particle size of ≤20 μm; take 100 mL of injection-grade soybean oil and heat it to 150 ° C in a container to sterilize it for 50 minutes, and cool it to room temperature; Add the pulverized ceftiofur hydrochloride to the soybean oil, and stir to disperse evenly; slowly add sorbitan fatty acid ester under stirring, stir evenly, stir evenly, continue stirring evenly, and completely disperse into a suspension; Put the ceftiofur hydrochloride suspension into four stainless steel containers in a high-performance ball mill, start the ball mill for 5-10 minutes, and grind the suspension so that more than 90% of the particles are ≤15 μm, to obtain the cephalosporin hydrochloride Thifur Suspension Injection.

[0029] The obtained ceftiofur hydrochloride suspension injection was tested according to the 2006 edition of the imported veterinary drug quality sta...

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Abstract

The invention discloses a method for preparing a ceftiofur hydrochloride suspension injection, which comprises the following steps: a) pulverizing ceftiofur hydrochloride in a pulverizer until the particle size of 90% particles is less than or equal to 20 mu m, and mixing; b) heating vegetable oil to 140-150 DEG C, keeping the temperature for 50-60 minutes for sterilization, and cooling to room temperature; c) adding the vegetable oil obtained in the step b) into the ceftiofur hydrochloride powder obtained in the step a), stirring uniformly, adding dehydrated sorbitol fatty acid ester, and continuing stirring uniformly until all the components are completely dispersed into a suspension; and d) refining the suspension obtained in the step c) with a homogenizer to obtain the ceftiofur hydrochloride suspension injection. Compared with the prior art, the method disclosed by the invention has the advantages of simple preparation technique, cheap and accessible raw and auxiliary materials, stable injection performance and obvious curative effect; compared with like products, the ceftiofur hydrochloride suspension injection has higher cost performance, and the product quality is superior to Relevant Standard for Pharmacopoeia, Edition 2010; and the invention is suitable for industrialized large-scale production, and therefore, has very wide application prospects.

Description

technical field [0001] The invention relates to a method for preparing a ceftiofur hydrochloride preparation, in particular to a method for preparing a ceftiofur hydrochloride suspension injection, which belongs to the technical field of veterinary drugs. Background technique [0002] Ceftiofur is a third-generation cephalosporin drug with broad-spectrum antibacterial activity. It is effective against various Gram-negative bacteria (such as E. coccus, streptococcus, etc.) and some anaerobic bacteria have strong antibacterial activity, and its molecular structure is stable and will not be destroyed by β-lactamase, so it will not produce drug resistance or cross-resistance. Selectively acts on transcription peptidase to block the synthesis of mucopeptide, so that the bacterial cell wall is lost to achieve bactericidal effect. This product has extremely low toxicity, and has the advantages of no milk resistance, no teratogenicity, carcinogenicity, genotoxicity and immunotoxici...

Claims

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Application Information

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IPC IPC(8): A61K9/10A61K31/546A61P31/04
Inventor 陈懿王文可曹建东方玮程瑶
Owner SHANGHAI TONGREN PHARM CO LTD
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